MAUDE Adverse Event Report: BELIMED AG CS 750; CART WASHER

Model Number	MST-H
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The component involved in the event is a long thin vertically mounted door frame panel.It is a cosmetic, non-functional component that is attached to the device by several adjustable press-click type fasteners.Some of the fasteners had not been adjusted correctly during initial installation in december of 2020.After two years of intensive use, which according to the user included loaded carts colliding with the door frame panel multiple times a day, the panel came loose and fell off.The component has been reattached by a service technician in accordance with the installation instructions.
Event or Problem Description
The right-hand load-side vertical door frame panel of the sterilizer fell off, almost hitting an employee.
Additional Manufacturer Narrative
The previously submitted b5 event description mistakenly identified the device as "sterilizer." in this supplement report, the event description has been revised to read "cart washer" instead of "sterilizer." the remaining information in the initial report was correct and remains unchanged, including the device description in section d.The following fields have been updated in this supplement report: b4, b5, g3, g6, h2, and h11.
Event or Problem Description
The right-hand load-side vertical door frame panel of the cart washer fell off, almost hitting an employee.

• Brand Name: CS 750
• Common Device Name: CART WASHER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 16866908
• Report Number: 3001061128-2023-00005
• Device Sequence Number: 14941916
• Product Code: MEC
• UDI-Device Identifier: 07640141626146
• UDI-Public: (01)07640141626146(11)191003
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MST-H
• Device Lot Number: 2010489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown